Rehab CARES In USA: Clinical Trial

University of Pennsylvania

Status: Completed

Conditions: Stroke; Hemiplegia

Treatments: Device: Robot-Assisted Therapy with Rehab CARES system; Other: Standard of Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05542121

853607

R42HD104325 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

In Phase 2, Patients in a community-based setting who have had a stroke will be evaluated by rehabilitation professionals and asked to perform a battery of clinical assessments before and after standard of care and robot assisted therapy with Rehab CARES system of simple force-feedback robots that are adapted to deliver single and group therapy.

Full description

In Phase 2, we will develop the hardware to allow three haptic robots to dock (a gym) and be configured to allow patients to play therapy games alone or collaboratively. We will test the safety and feasibility of the gym in a community-based rehabilitation setting. We will treat 36 patients randomized to either a control group getting standard of care therapy and a robot group receiving standard of care with upper limb therapy being given using the robot gym instead of an occupational therapist. Therapy will occur over 4 weeks with two follow-up assessments. Key milestones will be to show that the robot group has the same or better functional outcomes, motivation, and adverse events as the control group. Also to show that the robot gym is a cost-effective solution to increasing access to quality rehabilitation care in low-resource, community-based settings. Success here will validate this potential solution, justify design changes revealed via user-feedback and a larger clinical trial.

Enrollment: 27 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 55 and older (based on who is admitted to the CBR site)
• >3 months post-stroke
• Stroke diagnosis
• Diagnosis of hemiparesis as a result of stroke (verified by radiology data)
• Motor control score on Upper Extremity Fugl-Meyer scale > 15 and < 60;
• Able to understand and speak
• Upper arm manual muscle strength scores >1
• Pain Scores < 8 based on NIH Pain Intensity Scale

Exclusion criteria

• no cerebellum lesions due to stroke
• severe cognitive function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 2 patient groups, including a placebo group

Standard of Care

Placebo Comparator group

Description:

60 min OT sessions; 3 sessions per week; for 4 weeks;-- augmented Standard therapy - consisting of PT, OT and SLP. Clinical Assessment (B1-pre, B2-post, B3-follow-up#1, B4-follow-up#2).

Treatment:

Other: Standard of Care

Robot-Assisted Therapy with Rehab CARES system

Experimental group

Description:

60 min sessions; 3 sessions per week; for 4 weeks;----of Upper Limb therapy using 1 or more affordable robots. Robot sessions can be group play and/or single play. Robot Assessment (B1-pre, B2-post, B3-follow-up#1, B4-follow-up#2)

Treatment:

Device: Robot-Assisted Therapy with Rehab CARES system